# K181883: FIREFLY® Midline Navigation Guide

- Pathway: 510(k) (Traditional)
- Applicant: Mighty Oak Medical, Inc.
- Decided: Oct 3, 2018 after 82 days
- Product code: PQC (Pedicle Screw Placement Guide)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K040583 (2004). 146 ancestors in all.
4 later devices descend from it; 1 cites it directly.
1 of 151 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162419: FIREFLY® Pedicle Screw Navigation Guide, Mighty Oak Medical, Inc. (2016) Summary page 4.

## Most influential descendants
- K203673: MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides) (2021), 3 descendants of its own
- K220888: MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides (2022), 1 descendant of its own
- K231515: MySpine Cervical Guides (2023), 0 descendants of its own
- K231483: MySpine Unilateral Guides (2023), 0 descendants of its own

## Indications for use
The FIREFLY® Midline Navigation Guide can be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its cleared indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures (T10-S2) intended for fusion, with the additional conditions listed below: Pedicle screw’s shank is straight along its longitudinal axis (i.e. not curved) Pedicle screw’s major and minor thread diameters are centered about the longitudinal axis Pedicle screw’s longitudinal axis matches the direction of insertion Pedicle screw is intended to be inserted into a pilot hole Pedicle screw’s diameter is larger than the pilot hole created with FIREFLY® Patient’s pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on preoperative scan Compatible pedicle screw spinal system instruments may be used with the FIREFLY® Midline Screw Navigation Guide Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used with the FIREFLY® Midline Navigation Guide to confirm pedicle integrity All other pedicle screw spinal system components and accessories (including non-guided taps) are to be used, after removal of the FIREFLY® Midline Navigation Guide, as directed by the pedicle screw spinal system’s instructions for use This device is intended for single use only.

Source page: https://510kreport.com/device/K181883
Methodology: https://510kreport.com/methodology